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Development of a Selective Inhibitor of NaV1.7 for the Treatment of Ocular Pain

Award Number: R44EY033267
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Development of a Selective Inhibitor of NaV1.7 for the Treatment of Ocular Pain - PROJECT SUMMARY The absence of safe and effective strategies for the management of ocular pain is motivating the development of a novel topical drug suitable for patient self-administration. Conventional local anesthetics, such as proparacaine, inhibit voltage-gated sodium channels (NaV) and are highly effective for the management of ocular pain in acute, in-office settings. However, these anesthetic agents block protective ocular reflexes and are toxic to the corneal surface, which limits their use to a few in-office administrations. Other agents, such as topical NSAIDs, are relatively ineffective at relieving ocular discomfort, or have side effects that limit their use. SiteOne Therapeutics has discovered a novel chemical series of exquisitely selective inhibitors of human NaV1.7, a voltage-gated sodium channel subtype implicated in the transmission of pain signals by human genetics. These compounds exhibit excellent dose-dependent analgesic effects in multiple animal models of acute and chronic pain including a rat dry eye model. In preclinical safety and efficacy studies, topical ocular administration is effective, safe, well tolerated, and leads to good intraocular exposure. The goal of this Phase 2 SBIR proposal is to advance IND-enabling development of a topical ocular analgesic product. The Specific Aims are to complete GLP nonclinical safety studies, drug product development, and to prepare the first GMP batch in order to initiate clinical studies to determine if the new topical drug has an adequate safety and efficacy profile to justify further clinical development for the treatment of ocular pain.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$178,118 )
2025	2022	SITEONE THERAPEUTICS, INC.	280 UTAH AVE STE 250	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Vision Research	000	2	4/28/2025	NON-COMPETING CONTINUATION	-$178,118
														Subtotal = -$178,118

Issue Date FY: 2022 ( Subtotal = $559,962 )
2022	2022	SITEONE THERAPEUTICS, INC.	351 EVERGREEN DR STE B-1	BOZEMAN	MT	59715	GALLATIN	USA	Vision Research	001	2	9/1/2022	NON-COMPETING CONTINUATION	$559,962
2022	2021	SITEONE THERAPEUTICS, INC.	351 EVERGREEN DR STE B-1	BOZEMAN	MT	59715	GALLATIN	USA	Vision Research	000	1	10/22/2021	NEW	$0
														Subtotal = $559,962

Issue Date FY: 2021 ( Subtotal = $1,081,115 )
2021	2021	SITEONE THERAPEUTICS, INC.	351 EVERGREEN DR STE B-1	BOZEMAN	MT	59715	GALLATIN	USA	Vision Research	000	1	8/27/2021	NEW	$1,081,115
														Subtotal = $1,081,115

Grand Total All Awards = $1,462,959

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Development of a Selective Inhibitor of NaV1.7 for the Treatment of Ocular Pain

Award Number: R44EY033267

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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